MHRA Issues Medical Device Alert Regarding Issues

A warning has been issued regarding the specific product lots of the Alaris SmartSite needle-free valve, which is manufactured by CareFusion.

The Medical and Healthcare products Regulatory Agency (MHRA)’s medical device alert outlines concerns of a risk of disconnection or an inability to disconnect from the SmartSite, stating that it could lead to delay in treatment due to several factors.

These include air entering the fluid path, replacement of a central catheter or PICC or the under-delivery and leakage of medication.

The MHRA added that the affected lot numbers are 13086202, 13086263, 13086309, 13095185, 13095913, 13095914, 13096487, 13096488, 13096489, 13105366, 13105478, 13106563, 13106710, 13106711, 13115316.

In addition, the national supply codes are:
• England NPC: FSW165
• Scotland SKU: 066032
• Northern Ireland BSO: does not have a PALS reference number
• Wales NSV: FSN342

The MHRA added that only product code 2000E7D is affected and other configurations or item numbers are not affected.

Expert Opinion

If medical professionals are going to be able to provide the best possible standard of care to patients, it is vital that the devices they have to use also meet the regulatory standard. <br/> <br/>"This is another case where concerns have been raised regarding a medical product and it is important that regulators properly understand and explain to clinicians how these problems have emerged, as well as what is being done to prevent recurrence in the future. <br/> <br/>"Problems that arise from use of medical products in practice put the role of medical device regulation in the spotlight and should mandate examination of the current framework, so that it becomes more effective in its ability to protect patients from potential risks." Kevin Timms - Solicitor